Cytosar-U Side Effects

Generic name: cytarabine

Medically reviewed by Drugs.com. Last updated on Jun 26, 2024.

Note: This document provides detailed information about Cytosar-U Side Effects associated with cytarabine. Some dosage forms listed on this page may not apply specifically to the brand name Cytosar-U.

Applies to cytarabine: parenteral conventional cytarabine injection, parenteral conventional cytarabine powder for injection, parenteral liposomal cytarabine injection.

Important warnings This medicine can cause some serious health issues

Experience of Supervising Clinician
• Conventional cytarabine: Use only under supervision of qualified clinicians experienced in therapy with antineoplastic agents.^{a b c c j} Consider possible benefits vs known risks of cytarabine treatment.^{a b c j}

• Liposomal cytarabine: Use only under supervision of qualified clinicians experienced in intrathecal therapy with antineoplastic agents; adequate diagnostic and treatment facilities must be readily available for management of complications.^d

Induction Therapy with Conventional Cytarabine
• Patients should be treated in a facility with laboratory and supportive resources sufficient to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity.^{a b c j}

• Risk of serious adverse effects, including myelosuppression with leukopenia, thrombocytopenia, and anemia.^{a b c j} Less serious adverse effects include nausea, vomiting, diarrhea, abdominal pain, oral ulceration, and hepatic dysfunction.^{a b c j} (See Cautions.)

Chemical Arachnoiditis with Intrathecal Liposomal Cytarabine
• Chemical arachnoiditis, a syndrome manifested principally by nausea, vomiting, headache, and fever, commonly occurs.^d If left untreated, may be fatal.^d (See Chemical Arachnoiditis Related to Liposomal Cytarabine under Cautions.)

• Administer dexamethasone to ameliorate symptoms and reduce incidence.^d (See Liposomal Cytarabine under Dosage and Administration.)

Side effects include:

IV, sub-Q, or IM administration of conventional cytarabine (the active ingredient contained in Cytosar-U) Myelosuppression, anorexia, nausea, vomiting, diarrhea, oral and anal inflammation or ulceration, hepatic dysfunction, fever, rash, thrombophlebitis, bleeding (all sites).

Intrathecal administration of conventional cytarabine: Nausea, vomiting, fever, transient headaches.

Intrathecal administration of liposomal cytarabine: Chemical arachnoiditis (neck rigidity, neck pain, meningism, nausea, vomiting, headache, fever, back pain, and/or CSF pleocytosis), asthenia, pain, confusion, somnolence.

No formal drug interaction studies conducted with liposomal cytarabine to date.

For healthcare professionals

Applies to cytarabine: injectable powder for injection, injectable solution.

Ocular

• Very common (10% or more): Hemorrhagic conjunctivitis, corneal disorder
• Common (1% to 10%): Photophobia, burning, visual disturbance, increased lacrimation, keratitis
• Uncommon (0.1% to 1%): Conjunctivitis
• Frequency not reported: Blindness^[Ref]

Nervous system

• Very common (10% or more): Somnolence
• Common (1% to 10%): Decreased level of consciousness, dysarthria, nystagmus
• Uncommon (0.1% to 1%): Neurotoxicity, neuritis, dizziness, headache, peripheral neuropathy, paraplegia (with intrathecal administration)
• Frequency not reported: Dizziness, neurotoxicity rash, coma, convulsion, peripheral sensory neuropathy, ataxia, tremor, coma, convulsions^[Ref]

Cardiovascular

• Uncommon (0.1% to 1%): Chest pain
• Very rare (less than 0.01%): Arrhythmia
• Frequency not reported: Pericarditis, cardiomyopathy^[Ref]

Hematologic

• Very common (10% or more): Bone marrow failure, thrombocytopenia, anemia, megaloblastic anemia, leukopenia, reticulocyte count decreased
• Common (1% to 10%): Bleeding (all sites), thrombophlebitis
• Frequency not reported: Reticulocytopenia, neutropenia, febrile neutropenia^[Ref]

Hypersensitivity

• Uncommon (0.1% to 1%): Anaphylactic reaction, allergic edema^[Ref]

Immunologic

• Very common (10% or more): Sepsis, infection
• Frequency not reported: Viral, bacterial, fungal, parasitic, or saprophytic infections, in any location in the body (sometimes fatal)^[Ref]

Local

• Uncommon (0.1% to 1%): Injection site cellulitis, injection site thrombophlebitis
• Frequency not reported: Injection site pain, injection site inflammation, injection site irritation, injection site sepsis^[Ref]

Musculoskeletal

• Very common (10% or more): Cytarabine (the active ingredient contained in Cytosar-U) syndrome (e.g., fever, myalgia, bone pain, occasionally chest pain, exanthema, maculopapular rash, conjunctivitis, nausea, malaise)
• Uncommon (0.1% to 1%): Myalgia, joint pain^[Ref]

Metabolic

• Common (1% to 10%): Anorexia, hyperuricemia^[Ref]

Psychiatric

• Frequency not reported: Personality change, confusion^[Ref]

Genitourinary

• Uncommon (0.1% to 1%): Urinary retention
• Frequency not reported: Amenorrhea, azoospermia^[Ref]

Hepatic

• Very common (10% or more): Hepatic function abnormal
• Common (1% to 10%): Liver enzymes increased
• Uncommon (0.1% to 1%): Jaundice
• Frequency not reported: Liver abscess, hyperbilirubinemia, hepatomegaly, Budd-Chiari-syndrome (hepatic venous thrombosis)^[Ref]

Respiratory

• Very common (10% or more): Pneumonia, acute respiratory distress syndrome, pulmonary edema
• Uncommon (0.1% to 1%): Shortness of breath^[Ref]

Other

• Very common (10% or more): Pyrexia^[Ref]

Renal

• Uncommon (0.1% to 1%): Renal dysfunction^[Ref]

Dermatologic

• Very common (10% or more): Alopecia, rash
• Common (1% to 10%): Skin ulceration, erythema, bullous dermatitis, vasculitis
• Uncommon (0.1% to 1%): Lentigo, palmar-plantar erythrodysesthesia syndrome, urticaria, pruritus, freckling, burning pain of palms and soles
• Very rare (less than 0.01%): Neutrophilic eccrine hidradenitis
• Frequency not reported: Skin bleeding^[Ref]

Gastrointestinal

• Very common (10% or more): Stomatitis, mouth ulceration, anal ulcer, anal inflammation, diarrhea, vomiting, nausea, abdominal pain
• Common (1% to 10%): Necrotizing colitis
• Uncommon (0.1% to 1%): Sore throat, esophagitis, esophageal ulceration, bowel necrosis
• Frequency not reported: Pancreatitis, bowel necrosis, GI ulcer, pneumatosis intestinalis, peritonitis, mucosal bleeding^[Ref]

Frequently asked questions

• What drugs are contained in Vyxeos?

Further information

Cytosar-U side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer